Acessa Health

Acessa Health Receives FDA Clearance For The Pro Vu System® – The Next Generation Advancement In Uterine Fibroid Treatment Technology

Acessa ProVu System® Now Available to Treat Women Suffering from Symptomatic Uterine Fibroids.

September 28, 2018–AUSTIN, aT.X., Acessa Health Inc., developer of the Acessa System®, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) and U.S. commercial availability of the Acessa System’s most advanced and proprietary technology: The Acessa ProVu System. A fully integrated radiofrequency ablation, ultrasound visualization and guidance mapping system to enable physicians to effectively and safely treat women with symptomatic uterine fibroids.  

The Acessa ProVu System is the third generation of Acessa’s first and only, minimally invasive, laparoscopic radiofrequency ablation technology with category 1 CPT reimbursement code and widely established coverage, specifically designed to treat women suffering from uterine fibroids. The system is clinically proven with long-term clinical data as a safe alternative to hysterectomy and is well established with nearly 3,000 procedures performed to date.

Uterine fibroids affect 70–80% of women under the age of 55. Hysterectomy is the second most common surgery performed on reproductive-aged women and it continues to be the primary treatment for uterine fibroids in the United States, while less invasive alternatives are underutilized and often not discussed with patients. “The FDA clearance of the Acessa ProVu is a significant step in terms of offer patients more minimally invasive options to treat fibroids” said Regina Benjamin, MD the 18th Surgeon General of the United States.

“The Acessa ProVu System is the most utilized and advanced procedure for laparoscopic radiofrequency ablation of symptomatic uterine fibroids. After treating over 300 cases to date, I am thrilled to incorporate the Acessa ProVu System in my practice” said Dr. Abraham Shashoua, Director of Minimally Invasive and Robotic Gynecologic Surgery at Advocate Illinois Masonic Medical Center.

“The next generation Acessa ProVu System provides a fully integrated and seamless approach to identifying and treating all available fibroids,” said David Eisenstein, MD the Director of Henry Ford Health System’s Center of Excellence in Minimally Invasive Gynecology “As the Principal Investigator of TRUST and Co-Investigator of Compare-UF, two large Fibroid treatment studies; in our initial experience, we saw easy tracking in complex conditions combined with an enhanced user interface, with the potential to optimize our overall treatment and reduce procedure times.”

“Acessa Health is delighted to usher in our next phase of innovation with the introduction of Acessa ProVu,” said Kim Rodriguez, President and Chief Executive Officer of Acessa Health Inc. “Each phase of innovation – the original Acessa System, Acessa Guidance System and now the Acessa ProVu System – represent a significant improvement in performance and the opportunity to further support our physician partners who help women suffering from uterine fibroid symptoms.”

About Acessa System

Unlike many alternative interventions, Acessa can treat nearly all sizes and locations of fibroids – including those outside the uterine cavity and within uterine walls. The Acessa procedure is a minimally invasive, outpatient treatment that involves two smalls incisions, uses radiofrequency ablation (or heat) to destroy each targeted fibroid by applying controlled energy through a small needle array. The destroyed tissue may then be completely reabsorbed. There is no cutting or suturing of uterine tissue, patients experience minimal post-procedure discomfort and typically return to normal activities in 3-5 days.

About Acessa Health Inc.

Acessa Health is a women’s health innovator dedicated to advancing minimally invasive, uterine-sparing solutions for women with symptomatic fibroids. The company introduced the use of radiofrequency ablation for the treatment of uterine fibroids and is continuing to develop technologies that improve the lives of its patients. Acessa Health’s headquarters are in Austin, TX. For more information, visit AcessaProcedure.com.

Contacts

Acessa Health, Inc.

Kim Rodriguez

krodriguez@acessahealth.com

310.897.8889

 

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